One-Year Effect on Levodopa Equivalent Daily Dose of Thalamic VIM Nucleus Stimulation Compared to Subthalamic Nucleus Stimulation in Patients With Parkinson's Disease (VIM vs NST)

April 24, 2025 updated by: JARDEL Amory, Central Hospital, Nancy, France
This study compares the effects of deep brain stimulation (DBS) of the thalamic VIM nucleus versus the subthalamic nucleus (STN) on the levodopa equivalent daily dose (LEDD) in patients with Parkinson's disease. The goal is to determine whether VIM stimulation, typically used for tremor, can also reduce medication needs. It hypothesizes that STN stimulation leads to greater LEDD reduction, but VIM may offer moderate benefits in selected case

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Thesis Summary:

Deep brain stimulation (DBS) is a well-established therapeutic option for patients with advanced Parkinson's disease. The two most commonly targeted structures are the subthalamic nucleus (STN) and the ventral intermediate nucleus (VIM) of the thalamus. While STN stimulation is known to allow a significant reduction in the levodopa equivalent daily dose (LEDD), the effects of VIM stimulation on medication dosage remain less clear, particularly in patients selected for predominant tremor.

Objectives:

To compare the evolution of LEDD one year after DBS targeting the VIM versus the STN in patients with Parkinson's disease.

To assess whether VIM stimulation also enables a meaningful reduction in dopaminergic medication.

To contribute to refining surgical indications based on the patient's clinical profile.

Hypotheses:

STN stimulation leads to a greater reduction in LEDD compared to VIM stimulation.

VIM stimulation, though primarily used for tremor control, may result in moderate LEDD reduction in specific patient profiles.

Surgical target selection should be personalized, considering not only motor symptom control but also the impact on medication requirements.

Study Type

Observational

Enrollment (Estimated)

94

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
    • Lorraine
      • Nancy, Lorraine, France, 54000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study will include patients with Parkinson's disease who underwent deep brain stimulation (DBS) surgery targeting either the subthalamic nucleus (STN) or the ventral intermediate nucleus (VIM) of the thalamus at the CHRU of Nancy between 2014 (DxCare arrivals) and 2024. Eligible patients must have a diagnosis of Parkinson's disease

Description

Inclusion Criteria:

  • Clinical diagnosis of Parkinson's disease
  • Underwent surgery for subthalamic nucleus (STN) or ventral intermediate nucleus (VIM) deep brain stimulation
  • Surgery performed at CHRU of Nancy
  • Surgery performed between 2014 (DxCare implementation) and 2024

Exclusion Criteria:

  • No clinical diagnosis of Parkinson's disease
  • No initial dopaminergic treatment
  • Surgery not performed at CHRU of Nancy
  • Death within 1 year following surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
VIM group
Patients in this group underwent deep brain stimulation (DBS) targeting the ventral intermediate nucleus (VIM) of the thalamus. VIM stimulation is primarily used for the control of tremor in Parkinson's disease patients, particularly those with tremor-dominant symptoms. This group includes individuals who were selected for DBS due to the prominence of tremor in their clinical presentation, with less emphasis on other motor symptoms such as bradykinesia or rigidity
NST group
Patients in this group underwent DBS targeting the subthalamic nucleus (STN). STN stimulation is commonly used in patients with advanced Parkinson's disease, particularly for those who experience motor fluctuations, dyskinesias, and who require a significant reduction in dopaminergic medication. This group includes patients who were selected for DBS based on their overall motor symptoms, including bradykinesia and rigidity, with or without tremor predominance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the levodopa equivalent daily dose (LEDD) between Parkinson's disease patients undergoing deep brain stimulation (DBS) targeting the VIM thalamic nucleus versus the STN.
Time Frame: The primary endpoint, which is the change in levodopa equivalent daily dose (LEDD), will be measured one year post-surgery in both the VIM and STN DBS groups.
To compare the one-year change in the levodopa equivalent daily dose (LEDD) between Parkinson's disease patients undergoing deep brain stimulation (DBS) targeting the VIM thalamic nucleus versus the STN.
The primary endpoint, which is the change in levodopa equivalent daily dose (LEDD), will be measured one year post-surgery in both the VIM and STN DBS groups.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 30, 2025

Primary Completion (Estimated)

July 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

April 12, 2025

First Submitted That Met QC Criteria

April 12, 2025

First Posted (Actual)

April 20, 2025

Study Record Updates

Last Update Posted (Actual)

April 25, 2025

Last Update Submitted That Met QC Criteria

April 24, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024PI211

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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